- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414959
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
August 28, 2017 updated by: Markus Zeitlinger, Medical University of Vienna
The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Methods: microdialysis, blood sampling, bronchoalveolar lavage
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Med. Univ. of Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
intubated patients, intensive care
Description
Inclusion Criteria:
- endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection
Exclusion Criteria:
- allergy to doripenem, hemodialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markus Zeitlinger, MD, Medical Universit of Vienna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (ESTIMATE)
August 11, 2011
Study Record Updates
Last Update Posted (ACTUAL)
August 29, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dori_MD_ICU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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